FDA recall Z-2114-2018

Product

Bivona¿ Tracheostomy Tube Tracheostomy Tubes

Reason for recall

Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.

Distribution

Domestic distribution to CA, FL, GA, ID, NJ, NM, OH, VA. International distribution to France.

Key facts

Status

Terminated

Initiation date

2018-04-02

Report date

2018-06-13

Termination date

2018-11-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2114-2018